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New balloon treatment for heart disease under real-world watch

NCT ID NCT07256249

Disease control Sponsor: Fundación EPIC Source: ClinicalTrials.gov ↗

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now This study
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Jun 27, 2026 · Last updated Aug 13, 2026 · Updated 8 times

Summary

This study is a registry that follows about 960 people with coronary artery disease who are treated with a special balloon coated with a drug called sirolimus. The balloon is used to open blocked heart arteries. Researchers will track heart-related events like death, heart attacks, or the need for repeat procedures over 12 months to see how safe and effective the treatment is in everyday practice.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Participants

About 960 people

The number the study aims to enrol. It can still change while the study runs.

Started

Dec 2025

Expected to finish

Jan 2027

An estimate. End dates often move.

Lead sponsor

Other sponsor

The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Who is studied

All patients treated with the Selution SLRTM device

Ages

18 years and older

Sex

Anyone

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

Inclusion Criteria: * Patients with age ≥18 years and; * Patients with coronary artery disease in whom, at the operator's discretion, treatment of a lesion in a native vessel, coronary graft or coronary restenosis is decided using the Selution SLRTM device; * Patient who has been informed of the characteristics of the study and has provided written informed consent. Exclusion Criteria: * Express refusal of the patient to participate in the study * Life expectancy of the patient of less than 12 months

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Conditions

The condition(s) this trial relates to.

cardiovascular disorder coronary artery disorder

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Cardiovascular diseases

How to take part

Only the study team decides who joins. These are the ways to reach them.

  1. The places running it

    14 sites in 2 countries. The list below names each one and where it is.

  2. The official record

    ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.

    Open the record ↗

  3. A doctor treating you

    A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.

Contacts and locations

Locations

  • Hospital Clinico Universitario de Santiago

    RECRUITING

    Santiago de Compostela, 15706, Spain

  • Hospital Prof. Doutor Fernando da Fonseca

    RECRUITING

    Amadora, Portugal

  • Hospital Universitari Germans Trias i Pujol

    RECRUITING

    Badalona, 08916, Spain

  • Hospital Universitari MútuaTerrassa

    RECRUITING

    Terrassa, 08221, Spain

  • Hospital Universitario Marqués de Valdecilla

    RECRUITING

    Santander, 39008, Spain

  • Hospital Universitario Virgen del Rocio

    RECRUITING

    Seville, 41013, Spain

  • Hospital Universitario de Canarias

    RECRUITING

    San Cristóbal de La Laguna, 38320, Spain

  • Hospital Universitario de León

    RECRUITING

    León, 24008, Spain

  • Hospital Universitario de Pontevedra

    RECRUITING

    Vilagarcía de Arousa, Pontevedra, 36619, Spain

  • Hospital Universitario de Torrevieja

    RECRUITING

    Torrevieja, 03186, Spain

  • Hospital de Faro

    RECRUITING

    Faro, Portugal

  • Hospital de Santa Cruz

    RECRUITING

    Carnaxide, Portugal

  • Hospital de la Santa Creu i Sant Pau

    RECRUITING

    Barcelona, 08041, Spain

  • Hospital del Mar

    RECRUITING

    Barcelona, 08003, Spain

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